BRUSSELS, Belgium: On 19 May 2020, the European Commission issued guidelines on EU-wide derogations for medical devices. The guidelines follow the commission’s earlier proposal to defer the date of application of the medical device regulation to 26 May 2021 in the light of the SARS-CoV-2 pandemic.
SARS-CoV-2 continues to disrupt medical device companies in their manufacturing operations, and as a result of a proposal by the commission, the European Parliament and the European Council adopted Regulation (EU) 2020/561 on 23 April 2020. This regulation defers the date of application of Regulation (EU) 2017/745 to 26 May 2021. At the same time, it defers the application of the provision repealing Council Directive (EEC) 90/38 on active implantable medical devices and Council Directive (EEC) 93/42 on medical devices.
EU-wide derogations concern the commission’s ability under the medical devices regulation to extend to the territory of the EU for a limited period the validity of a national authorisation, allowing the placement on the market of medical devices in respect of which the relevant conformity assessment procedures have not been carried out. This can be authorised because the devices’ use is considered to be in the interest of public health or patient safety or health. This enables the commission to address potential shortages of vitally important medical devices across the EU in an effective manner.
The aim of the new guidelines is to provide information on the adoption of EU-wide derogations for medical devices, in particular regarding the criteria that the commission will take into account when determining whether the extension to the territory of the EU of a national derogation is necessary and justified. The document also provides information on the adoption process, including the role of member states, and the general conditions that the commission will set for EU-wide derogations. In general, the commission will run through the following three steps when considering whether an EU-wide derogation should be adopted:
- consult the member states by means of a medical device coordination group to identify whether a notified national derogation for a certain medical device could be of EU relevance;
- assess whether the procedural requirements referred to in Subsection A of the guidelines have been met; and
- determine whether, based on the requirements referred to in Subsection B of the guidelines, adopting an EU-wide derogation in the case at hand would be duly justified.
The guidelines, however, acknowledge the fact that EU-wide derogations should be regarded as a measure of last resort and should only be considered by the commission in exceptional cases to ensure patient health or safety or to protect public health.
The commission’s guidelines can be accessed here.
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